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By Edwin Bills, Christie Johnson, and Jayet Moon | On Feb. 2, 2024, the FDA set a new cornerstone in the medical device regulatory landscape by releasing the new Quality Management System Regulation (QMSR), a forward step that is scheduled to be fully implemented by Feb. 2, 2026. Let's take a closer look, including the role of ISO 13485, expectations for compliance with ISO 14971, and more. |
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By Renée Bailey, BlackHägen Design | One of the most integral components in the development of drug-device combination products is the use-related risk analysis (URRA) and its applicability to the overall human factors engineering process. Deficiencies in the URRA are a leading cause of delays with FDA submissions. |
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By Raj Tumbad, Freyr Solutions | In 2021, Australia's Therapeutic Goods Administration implemented reforms covering a wide range of software, including software as a medical device (SaMD) with the goals of clarifying the scope of regulated software products, introducing new classification rules, and updating the principles governing software-based medical devices. |
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| Improving Medical Device Sustainability | Article | By Molly Wagle, DSM Biomedical | Product design, production methods, and supply chain can be leveraged to positively impact sustainability through effective planning. |
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| Current Trends In Medical Kit Packaging | Article | B. Braun OEM Division | Today’s version of the medical procedure kit comprises stackable, efficient, sterile, and identifiable trays or pouches stocked with essential equipment for specific surgeries, tests, and examinations. |
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